FDA.reportPublic FDA data

Surgical BioModel

Primary DI
09349797001366
Brand
Surgical BioModel
Company
ANATOMICS PTY LTD
Model
BM-IMPLANT
Catalog number
BM-IMPLANT
Device description
Biomodel for implant reference
Published
2020-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate
JOFPolymer, Ent Synthetic, Porous Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
JOFPolymer, Ent Synthetic, Porous PolyethyleneEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171037000PoreStar Patient Specific ImplantAnatomics Pty, Ltd.2017-12-27JOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349797001366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349797001366093497970013669349797001366

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61395298088contact@anatomics.com

Regulatory Flags#

DUNS number
755739307
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349797000093Surgical TemplateTP-BRTTP-BRT2020-11-26
09349797002530StarPoreCI-STARPORE-S2CI-STARPORE-S22020-04-03
09349797002547StarPoreCI-STARPORE-M2CI-STARPORE-M22020-04-03
09349797002554StarPoreCI-STARPORE-L2CI-STARPORE-L22020-04-03
09349797002561StarPoreCI-STARPORE-XL2CI-STARPORE-XL22020-04-03
09349797001700StarPoreCI-STARPORE-OTCI-STARPORE-OT2020-02-17
09349797002387StarPoreCI-STARPORE-SAMPLECI-STARPORE-SAMPLE2020-02-10
09349797000192StarPoreCI-STARPORE-SCI-STARPORE-S2020-01-08
09349797000208StarPoreCI-STARPORE-MCI-STARPORE-M2020-01-08
09349797000215StarPoreCI-STARPORE-LCI-STARPORE-L2020-01-08
09349797000222StarPoreCI-STARPORE-XLCI-STARPORE-XL2020-01-08
09349797000239StarPoreCI-STARPORE-OCI-STARPORE-O2020-01-08

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